NCT04355507

Brief Summary

The purpose of this study is to build a large dataset of Computed Tomography (CT) images for identification of accurate CT criteria and development of deep learning-based solutions for diagnosis, quantification and prognostic estimation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,735

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2020

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

April 17, 2020

Last Update Submit

January 19, 2026

Conditions

COVID-19

Keywords

Computed Tomography (CT)COVID-19Artificial intelligenceDeep Learning

Outcome Measures

Primary Outcomes (1)

  • Predictive values of CT criteria

    Sensibility specificity positive and negative predictive values of CT criteria with RT-PCR results as standard of reference.

    1 month

Secondary Outcomes (4)

  • Accuracy of CT composite severity score

    1 month

  • Accuracy of deep-learning based score

    1 month

  • Predictive values of deep-learning based diagnostic algorithms

    1 month

  • Dice similarity coefficient between manual and automated segmentation of lung disease abnormalities

    1 month

Study Arms (1)

Patients with suspicions of COVID-19 pneumonia

Patients with suspicions of COVID-19 pneumonia

Diagnostic Test: Chest computed tomography (CT)Diagnostic Test: Reverse-transcription polymerase chain reaction (RT-PCR)

Interventions

Chest computed tomography (CT)DIAGNOSTIC_TEST

Chest computed tomography (CT) examination

Patients with suspicions of COVID-19 pneumonia
Reverse-transcription polymerase chain reaction (RT-PCR)DIAGNOSTIC_TEST

Identification of viral RNA by reverse-transcription polymerase chain reaction

Patients with suspicions of COVID-19 pneumonia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspicions of COVID-19 pneumonia

You may qualify if:

  • Age\>18 years
  • CT examination performed for suspicion or follow-up of COVID-19
  • Non opposition for use of data

You may not qualify if:

  • Unavailability of RT-PCR results for SARS-Cov-2
  • Failure of CT image anonymized export

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin Hospital

Paris, 75014, France

Location

Related Publications (4)

  • Ai T, Yang Z, Hou H, Zhan C, Chen C, Lv W, Tao Q, Sun Z, Xia L. Correlation of Chest CT and RT-PCR Testing for Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases. Radiology. 2020 Aug;296(2):E32-E40. doi: 10.1148/radiol.2020200642. Epub 2020 Feb 26.

    PMID: 32101510BACKGROUND

  • Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

    PMID: 32171076BACKGROUND

  • Ko WC, Rolain JM, Lee NY, Chen PL, Huang CT, Lee PI, Hsueh PR. Arguments in favour of remdesivir for treating SARS-CoV-2 infections. Int J Antimicrob Agents. 2020 Apr;55(4):105933. doi: 10.1016/j.ijantimicag.2020.105933. Epub 2020 Mar 6. No abstract available.

    PMID: 32147516BACKGROUND

  • Revel MP, Boussouar S, de Margerie-Mellon C, Saab I, Lapotre T, Mompoint D, Chassagnon G, Milon A, Lederlin M, Bennani S, Moliere S, Debray MP, Bompard F, Dangeard S, Hani C, Ohana M, Bommart S, Jalaber C, El Hajjam M, Petit I, Fournier L, Khalil A, Brillet PY, Bellin MF, Redheuil A, Rocher L, Bousson V, Rousset P, Gregory J, Deux JF, Dion E, Valeyre D, Porcher R, Jilet L, Abdoul H. Study of Thoracic CT in COVID-19: The STOIC Project. Radiology. 2021 Oct;301(1):E361-E370. doi: 10.1148/radiol.2021210384. Epub 2021 Jun 29.

    PMID: 34184935RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Marie-Pierre REVEL, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 21, 2020

Study Start

March 1, 2020

Primary Completion

October 16, 2020

Study Completion

October 16, 2020

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)